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eCF BoF Webinar: Principal Investigator's Signature: Best Practices

Wed, 27-April-2022

Event date: 27/04/2022 Export event

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

Birds-of-a-Feather Webinar:  Principal Investigator's Signature: Best Practices

Date:  27-April-2022          Duration: One hour

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

For This Topic:  The eCF’s PI Signature Working Group have updated their 3-year-old document.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  The Round-table discussion will include:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Time – this Round-table is offered at 2 times, both on Wed, 27-April-2022. We hope you will find one of them convenient for your participation.

Webinar A: Europe/Asia Pacific facing:

Webinar B: Americas/Europe facing:

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )       eCF Members can use this link to register:   Webinar Registration (eclinicalforum.org)

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Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

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